It is now possible to perform cervical cancer screening from the comfort of your own home with a prescribed at-home test approved by the U.S. Food and Drug Administration. The approved test enables people to collect their own vaginal samples at home and mail them in to a certified lab for testing.
The test provides screening for cervical cancer by testing for the presence of the human papillomavirus (HPV), which is the virus that causes about 95-99% of cervical cancers. An abnormal result requires follow-up with a physician for additional testing in person.
“This new technology is exciting, as by far the biggest risk factor for cervical cancer is not being screened. With the potential for self-testing for patients at average risk, we hope that we can expand screening to more people,” says Stephanie Alimena, MD, a surgical oncologist in the Gynecologic Oncology Program at Dana-Farber Brigham Cancer Center.
Cervical cancer is highly preventable with HPV vaccination and cervical cancer screening. Yet approximately one-quarter of women in the U.S. are behind on screening. Black, Hispanic/Latinx, Native American, and uninsured people also face disparities related to cervical cancer, facing a higher risk of death and risk of undertreatment for their cancers, in part due to challenges accessing screening.
How does the at-home cervical cancer screening test work?
A traditional Pap smear involves a visit to a doctor. The test can be unpleasant as the doctor swabs for cells on the cervix, which is at the opening of the uterus and is found deep inside the vagina. The samples collected can be tested for cellular changes (this is called a Pap test), for cellular changes and the presence of HPV (this is called a co-test), or for HPV (this is called primary HPV testing).
The at-home cervical cancer screening test, which is made by Teal Health, differs in a few important ways:
- It is designed to support the collection of a sample at home using a wand. The wand collects cells from the vagina, which the patient packages according to instructions and mails to a lab for processing. The laboratories that process the samples are the same labs that process samples from Pap smears performed by doctors.
- The samples are tested for HPV using a primary HPV screening test. This is the test recommended in screening guidelines from the American Cancer Society and the United States Preventive Services Task Force and is more likely to catch disease than a Pap test or co-test. If HPV test results are abnormal, then a Pap test is run as well off the same sample.
- Results are reported back via an app and a telehealth visit is provided to help guide patients who receive abnormal results.
What do I do if I receive an abnormal result on an at-home cervical cancer test?
If you receive abnormal results from the HPV test, more diagnostic testing is needed. Additional diagnostics can include:
- A Pap test, which is typically automatically run off the same sample if the HPV test is abnormal.
- A colposcopy, which involves a physician examining the cervix under a microscope and potentially obtaining a biopsy if it appears abnormal.
It is important to follow-up using the telehealth services available with the technology and with an in-person visit with a physician.
“It is vital that patients with abnormal results speak to a physician about what additional testing they need afterward,” says Alimena. “Additional testing will enable a physician to diagnose cervical cancer or precancerous changes if they are present and provide treatment.”
Who can use the at-home cervical cancer screening test?
The at-home cervical cancer screening test is approved for use by people who are between ages 25 and 65 and have a cervix (e.g., they have not had a cervix-removing hysterectomy). It is recommended for people who are at “average risk” of cervical cancer.
People at average risk:
- Have had regular screening in the past,
- Have never had an abnormal cervical cancer screening test or the HPV virus,
- Are not immunosuppressed,
- Have no symptoms related to cervical cancer such as abnormal uterine bleeding.
If someone has had abnormal pap or HPV testing in the past, they are not considered at average risk.
It is not recommended for people who are pregnant, have a history of a cancer in the reproductive system, or who have HIV, DES exposure, or immunosuppression.
Does at-home cervical cancer screening replace regular cervical cancer screening or Pap smears?
The at-home test is an alternative to cervical cancer screening by a provider in a doctor’s office. Your regular doctor can’t order the test for you. Rather, the test is provided via a prescription through the Teal Health telehealth service providers.
The at-home test does not replace regular gynecologic exams, which provide a health check of the reproductive organs, including breasts, vagina, uterus, fallopian tubes, and ovaries.
Who needs cervical cancer screening and how often should it be done?
Adults with a cervix should be screened for cervical cancer regularly. Cervical cancer screening is recommended even if you have received HPV vaccination or if you are not sexually active, or if you identify as LGBTQ+.
Cervical cancer screening guidelines recommend:
- Ages 21-29: Pap test every 3 years.
- Ages 30-65: Primary HPV testing every 5 years. If that option is not available, alternatives are co-testing every 5 years, or a Pap test every 3 years.
- Ages 66 and over: Screening is required unless prior tests have been negative in the last 10 years, and the person has not been diagnosed with cervical cancer or with precancerous changes of the cervix in the prior 25 years. Following these criteria to safely stop screening is important, as approximately 20% of cervical cancer cases are diagnosed in people over age 65. It is important to discuss possible risk factors, such as a new partner, HIV infection, immunosuppression, or previous HPV infection with your doctor.
If you have had prior abnormal cervical cancer testing, note that these guidelines do not apply, and your physician may recommend more frequent testing.
Note that for in-office tests, the primary HPV test might not be available, and a doctor might instead follow guidelines to do a co-test every five years or a Pap test every three years.
About the Medical Reviewer
Dr. Alimena is a Member of the Faculty in the Department of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. Her research strives to understand sources of disparities in outcomes for patients at-risk for and diagnosed with gynecologic malignancy. She has clinical interests in treating all types of gynecologic cancers, including ovarian cancer, endometrial cancer, cervical cancer, vaginal cancer, and vulvar cancer. She sees patients at the Brigham and Women’s Hospital main campus, the Dana Farber Cancer Institute main campus, and the Dana Farber Cancer Institute Chestnut Hill location.